CLS Services

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Technical Expert QC Operations - COVID-19 Release & Stability support

Leiden
Gepubliceerd: ongeveer 1 maand geleden
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Biologics B.V., we are searching for a Technical Expert QC Operations - COVID-19 Release & Stability support.

Keywords

  • eLIMS
  • Quality systems
  • Data management

Job description
Do you like to work directly on the process of the JnJ Covid-19 vaccin in a supportive rol as Technical Expert? Are you experienced in eLIMS systems? Then we are looking for you!

The position will support the deployment and maintenance of the digitalization/automation project for the J&J labs. The laboratory mission is to increase lab reliability through automation of processes and reduction in manual transcription of data, improved electronic control and data capture, delivering Data Integrity and Efficiency value using global lab systems and interfaces. You take ownership by completing any incoming requests in a timely manner, in order to maintain high quality data. This position is expected to fully understand the sites master data requirements and lab processes to ensure all configurations are accurate and complete. You are responsible for mentoring, leading and training team members.and you are able to lead projects within QC Operations, e.g. implementation of iLABs projects, harmonization / standardization of processes. You interact closely with IT and speaks business language to customers

Main tasks:
  • Build & Maintenance of DS & DP Specifications and Stability studies & Work items to support Stability testing;
  • Maintain CBER automated reports;
  • Build & Maintenance of Workitems, Super sample templates to support IPC’s and release testing;
  • Support Eurofins with Stability study executions (cfr Stability coordinator role in stab labs);
  • eLIMS SKU (Site Key User) role for Eurofins: Update of eLIMS EXT roles stability Access & Securities, SOP’s, training, User Access Management, level 1 & 2 support;
  • eLIMS Project Management - meetings, planning, documentation (SOP’s, CC’s, etc. )


Who we're looking for
For this role, we are looking for a Bachelor's or Master's candidate with at least 4 years of working experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) with knowledge and experience with LIMS. You have broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management. Experience in Master Data Management is required. Extensive other experience with analytical testing, Quality Control or IT is preferred.
As a person, you are able to manage multiple issues, organize activities, are accurate and set priorities.
Are you the communicative eLIMS expert we are looking for?

Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.



Additional vacancy information
Reference: A2100008
Contract: Temporary contract with CLS Services
Education: HBO/BSc.
Terms: Salary: >2600
Days of leave: 25 + 11
Work from home is possible
See here our other employment terms for this vacancy
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555

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Vacature details

Fulltime / parttime

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